Strength200 mg
Forminjection
Adult dose and duration200 mg subcutaneously every two weeks, and the steroid comes down alongside it. US label verbatim: "The recommended dosage of KEVZARA is 200 mg once every two weeks given as a subcutaneous injection, in combination with a tapering course of systemic corticosteroids. KEVZARA can be used as monotherapy following discontinuation of corticosteroids." The label stops it rather than reducing it if the blood tests turn: "Discontinue KEVZARA if the patient develops neutropenia (using ANC results obtained at the end of the dosing interval), thrombocytopenia, or liver enzyme abnormalities." - Continued while the steroid is being withdrawn, then reviewed. The label's own framing is that it can carry on as monotherapy "following discontinuation of corticosteroids", so the end point is a patient off prednisolone rather than a fixed number of weeks.
Paediatric doseAdult-only condition - paediatric section not applicable
Dose sourceKEVZARA (sarilumab) injection US prescribing information, boxed warning, section 1.2 Polymyalgia Rheumatica, section 2.1 General Considerations Prior to Administration and section 2.3 Recommended Dosage for Polymyalgia Rheumatica (DailyMed SetID 827bc01c-d379-4266-a18c-c7f904b76af3)
WhyThe disease article names the drug and the exact patient, verbatim: "Sarilumab is a biologic medication approved for treating polymyalgia rheumatica in adults who have not responded adequately to corticosteroids or cannot tolerate corticosteroid tapers." The US label's indication section names the same disease in almost the same words, verbatim: "KEVZARA is indicated for treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper." The card carried prednisolone and methotrexate; sarilumab is the only drug licensed for this disease by name, and it is the one the article reaches for when the taper fails. Egypt registers KEVZARA 200 mg pre-filled syringes at about 14,050 EGP for two, so cost is part of the conversation. Rheumatology starts it; the regimen is printed so a shared-care clinic can recognise it and knows to hold it during infection.
Cautions- RED FLAG - boxed warning, serious infection. US label verbatim: "Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of KEVZARA in patients with an active infection." That last clause matters here because almost every patient on this card is also on prednisolone.
- Tuberculosis is screened for before the first injection, not after. US label verbatim: "Prior to initiating KEVZARA, test patients for active and latent tuberculosis (TB). KEVZARA should not be administered to patients with active TB. If positive for latent infection, consider treating for TB prior to KEVZARA use." The boxed warning adds that TB "may present with pulmonary or extrapulmonary disease". Latent tuberculosis is common in Egypt.
- Baseline bloods gate the first dose. US label verbatim: "Treatment initiation with KEVZARA is not recommended in patients with an absolute neutrophil count (ANC) below 2000 per mm3, or platelet count below 150,000 per mm3." and "Treatment initiation with KEVZARA is not recommended in patients with or who have alanine transaminase (ALT) or aspartate aminotransferase (AST) above 1.5 times the upper limit of normal (ULN)." Lipids are measured at baseline too.
- IL-6 blockade blunts the inflammatory markers you would otherwise use to judge the disease and to detect infection. A normal CRP on this drug does not exclude sepsis, and the fever may be absent.
- Not to be stacked on another biologic. US label verbatim: "Avoid using KEVZARA with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection."
- The steroid-related work does not stop. Disease article verbatim: "Vitamin D and calcium supplementation are routine recommendations for patients on long-term steroids. Bisphosphonate prophylaxis is recommended for patients in moderate to high fracture risk categories".
- New headache, jaw claudication or visual loss in a patient with polymyalgia is giant cell arteritis until proved otherwise, and that is a same-day, high-dose-steroid emergency - not a reason to bring the biologic forward.